Ortho’s CE-Marked VITROS^® SARS-CoV-2 Antigen Test Detects Asymptomatic COVID-19 Individuals

• Ortho’s VITROS^® SARS-CoV-2 antigen test can detect SARS-CoV-2 infection in asymptomatic individuals.
• The low-cost VITROS antigen test can run up to 130 tests per hour and is a viable choice for frequent, high-throughput testing and monitoring of large community populations.

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its CE-marked VITROS® SARS-CoV-2 antigen test can now detect SARS-CoV-2 infection in asymptomatic individuals.

The low-cost VITROS antigen test can run up to 130 tests per hour and is able to detect SARS-CoV-2 infection in individuals who do not report any symptoms, making it a viable choice for frequent, high-throughput testing and monitoring of large community populations including health care workers, schools, sporting organizations, manufacturing facilities, assisted and institutionalized living, and other communities with access to VITROS® instruments.

Ortho’s antigen test is offered with 92.3% sensitivity with samples with a cycle threshold (CT— a measure of viral load) count of less than 30. Samples with CT values of 30 or greater are less likely to contain live virus that are capable of replicating in cell cultures, suggesting less infectivity.

“Cases of COVID-19 continue to rise globally, yet there remains significant need for reliable testing and faster results reporting due to the lack of availability, high expense and infrastructure challenges of polymerase chain reaction (PCR) testing,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “Ortho’s antigen test enables accurate, frequent mass testing of both symptomatic and asymptomatic individuals at a lower cost than PCR. By using analyzers already in place across the world, the test can be instrumental in controlling the spread of the disease.”

The VITROS SARS-CoV-2 Antigen test is the latest addition to Ortho’s COVID-19 testing solutions. Ortho also manufactures two COVID-19 antibody tests—Total and IgG—which were granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) in April and achieved CE Mark in May. Millions of COVID-19 tests per day can be processed through the more than 5,600 Ortho immunodiagnostic systems currently in operation worldwide. 

For its VITROS SARS-CoV-2 Antigen test, Ortho achieved CE Mark on October 23, 2020, allowing test distribution throughout the European Union (EU). Ortho also submitted EUA and Emergency Use Notification (EUN) to the FDA on October 23, 2020. The FDA posted the Ortho SARS-CoV-2 antigen test on their website on October 30, 2020, allowing for distribution across the U.S. while the EUA is in review. The addition of asymptomatic claims is currently limited to the CE-Marked product while the FDA EUA review of Ortho’s antigen test is ongoing.

The VITROS SARS-CoV-2 Antigen test is also the first test to run on Ortho’s high-throughput, fully automated VITROS® platform using respiratory specimens, rather than the blood and body fluid samples typically run by the systems. Samples for Ortho’s SARS-CoV-2 antigen test can be collected in bulk, and stored at room temperature for up to 24 hours or 48 hours if refrigerated. Contrary to PCR tests, which can take hours to obtain results, Ortho’s COVID-19 antigen test can run on Ortho’s high-throughput VITROS® Systems. 

Ortho’s SARS-CoV-2 antigen test runs on Ortho’s VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 5600 Integrated System. An additional benefit to Ortho’s VITROS Systems is that they are self-contained and do not require an external water source to run, making them suitable for myriad locations that may not have accessible plumbing.

The test, now commercially available, is manufactured in Rochester, New York. 

This project has been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response under contract number 75A50120P00103. 

The VITROS SARS-CoV-2 Antigen test has met the requirements for a diagnostic test cited in Section IV, Policy C in the following FDA Guidance: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff --Document issued on the web on May 11, 2020. The VITROS SARS-CoV-2 Antigen test has been validated but the FDA’s independent review of the labeling and validation is pending.

The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved.  They have been authorized by the FDA under an Emergency Use Authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.